Abstract:
Background: A non-invasive ventilation (NIV) mask has been designed to deliver NIV with expiratory washout (EW) to improve efficacy of ventilation by optimizing clearance of expired gases from the anatomic dead-space. This study compared the performance and comfort of a novel investigational mask with EW with a conventional mask during NIV therapy.Methods: In this pilot cross-over study, participants with severe stable chronic obstructive pulmonary disease (COPD) attended a single visit to receive bi-level NIV through two masks; the investigational mask with EW, and a conventional mask. The order of mask use was randomly allocated, and each mask was used for 60-minutes with a 30-to-60-minute washout in between. The primary outcome was transcutaneous carbon dioxide (PtCO2) at 60 minutes. Other physiologic and NIV device variables were also assessed.Results: The mean difference [95% CI] in the PtCO2 between the investigational and conventional masks at 60 minutes, adjusted for baseline, was -0.74 mmHg [-2.81 to 1.33, P=0.45]. The investigational mask with EW elicited a lower tidal volume (-128.7 mL [-190.0 to -67.3], P<0.001) and minute ventilation (-2.28 L·min-1 [-3.12 to -1.43], P<0.001), and a higher leak (7.96 L·min-1 [4.39 to 11.54], P<0.001), than the conventional mask. There were no significant differences in other physiological responses or ratings of dyspnoea or comfort.Conclusions: NIV therapy delivered using a novel mask with EW was similarly effective at reducing PtCO2, while the delivered tidal volume and minute ventilation were significantly lower, when compared to a conventional mask in participants with severe COPD.
摘要:
背景:设计了一种无创通气(NIV)面罩,可通过呼气冲洗(EW)来输送NIV,以通过优化从解剖死腔中清除呼出气体来提高通气效率。这项研究比较了在NIV治疗期间,具有EW的新型研究性口罩与常规口罩的性能和舒适度。方法:在这项试点交叉研究中,患有严重稳定期慢性阻塞性肺疾病(COPD)的参与者参加了一次访问,通过两个口罩接受了双水平NIV;带有EW的研究性口罩,一个传统的面具。口罩的使用顺序是随机分配的,每个面罩使用60分钟,其间有30到60分钟的冲洗时间。主要结果是在60分钟时经皮二氧化碳(PtCO2)。还评估了其他生理和NIV装置变量。结果:60分钟时,研究性口罩和常规口罩之间的PtCO2平均差[95%CI],针对基线进行了调整,为-0.74mmHg[-2.81至1.33,P=0.45]。带有EW的研究性口罩引起较低的潮气量(-128.7mL[-190.0至-67.3],P<0.001)和分钟通气量(-2.28L·min-1[-3.12至-1.43],P<0.001),和更高的泄漏(7.96L·min-1[4.39至11.54],P<0.001),比传统的面具。其他生理反应或呼吸困难或舒适度等级没有显着差异。结论:使用带有EW的新型面罩进行的NIV治疗在降低PtCO2方面同样有效,而递送的潮气量和分钟通气量则显着降低,与重度COPD参与者的常规口罩相比。